MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS: TEN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from china reports an event as follows: this report is being filed after the review of the following journal article: hongkuan l.,zhiping z., sheng l.C., (2018) minimally invasive retrograde elastic nailing for displaced clavicle fractures in children, chinese journal of orthopaedic trauma, september , vol.31, no.9, pages 1-9 (china).This study aims to study the application and effect of retrograde titanium elastic nail fixation under closed reduction in the treatment of displaced clavicle fractures in children.From january 2014 to november 2016, 26 children, among whom there were 14 males and 12 females, aged 7-14 years, with mean one of 9.2 years, with displaced clavicle fractures were treated with closed reduction and retrograde internal fixation using titanium elastic intramedullary nail (ten) of ao (synthes, switzerland).Patients were followed up for 6 to 12 months.During the operation, 2 cases of lateral end screw insertion penetrated the cortex, which was corrected after adjusting the direction of screw head.After operation, 2 cases had local skin pressure and skin irritation symptoms, which disappeared after removal of internal fixation.This report is for an unk - end cap: ten.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - END CAPS: TEN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14981300
• MDR Text Key: 295674434
• Report Number: 8030965-2022-04721
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other